bureau of enforcement investigative services unit...

Bureau of EnforcementInvestigative Services Unit

PHARMACY INSPECTION OVERVIEW

CONTINUING EDUCATION TRAINING

November 8, 2018Orlando, Florida

Introduction• Workshop Purpose

• Topics• Program History• Introduction of Inspectors• Program Statistics• Environmental Monitoring• Hand Hygiene and Garbing

Introduction• Topics

• Certifications• Cleaning• Media Fills/ Gloved Finger testing• Compounding Records• Class III Permits

Program History

• New England Compounding Center (NECC)• 7 deaths and 25 cases of meningitis in Florida

• Board adopted USP 797 on October 1, 2014.

Program History

• HB7077 (2014)• Defined Compounding and Outsourcing Facilities

• Established a Non-Resident Sterile Compounding Permit

• Granted authority to conduct non-resident inspections

Inspectors

• Six (6) Senior Pharmacists• 156 years of licensure• 125 years of practice• 27 years of regulatory experience

Program Statistics

•508 Sterile Compounding Inspections

•34 possible Non-Resident Inspections

•Top Deficiencies•95•98•68•99

Program Statistics

•Top Deficiencies•73•93•78•89•72•90

Presentation Topics

• Environmental Monitoring: #’s 60, 68, 71, 72, 73, 74, 75, 89

• Hand Hygiene and Garbing: #’s 57, 86, 87, 88, 89, 90, 91, 92, 97, 98

• Certifications: #’s: 41, 42, 51, 52, 53, 54, 55, 56, 59

Presentation Topics

• Cleaning: #’62, 66, 77, 78, 79, 83, 84, 85, 97, 109, 110

• Media Fills/ Gloved Finger testing: #’s: 93, 94, 95, 99, 100

• Compounding Records: #’s: 118

Environmental Monitoring

• Why is it performed? • Control• Identify• Gather Data• Information

• What it is NOT• Not Highly Recoverable• Not Always Repeatable• Not Always Linked to a Direct Cause and Effect

• Not Proof of the Absence of Contamination

• Surface Sampling: Monitoring Work Practices• Effectiveness of Cleaning• Proper Aseptic Technique• Personnel Practices• Material Movement

• What Media? • How to Incubate• General media TSA with neutralizers

• Viable AIR Sampling• When• Where• How Much

• Importance of Environmental Sampling Plans• Risk Assessment• Locations• Method of Collection• Frequency and Sampling Volume of Air • Time of Day Related to Compounding • Action Levels

• What Do I do When Action Level Exceeded?• Identification• Investigation• Remediation

• Gram Positive Bacteria • Gram Negative Bacteria• Fungi

Questions?

Hand Hygiene and GarbingCorrect Order of Donning PPE

Hand Hygiene and GarbingCorrect Process for Donning PPE

• Remove outer garments, jewelry, cosmetics, and artificial nails prior to donning PPE

• Don shoe covers, head/facial covers, and face masks

• Cleanse hands and forearms to the elbow with facility-approved soap and water for at least 30 seconds

Hand Hygiene and GarbingCorrect Process for Donning PPE

• Completely dry hands and forearms using a lint-free towel

• Don non-shedding gown USP 39-NF-34

• Apply Persistent activity hand scrub and allow for it to dry

• Don sterile gloves

• If ISOLATOR-Don sterile gloves which come in contact with the vials used in compounding inside the main chamber using the glove port

• Spray or wipe gloved hands with sterile Isopropyl Alcohol, allow to dry

• Routinely disinfect gloves when reaching outside of ISO 5 to obtain products to use in compounding prior to reinitiating compounding

• May reuse gowns if maintained in ISO 8 for that shift

USP 39-NF 34

Hand Hygiene and GarbingDonning of Impermeable Chemo Gown

https://asp.pharmacyonesource.com/images/simplifi797/ivroomflow.pdf accessed Oct 11, 2018 Best Practices for Compounding Garbing November 2016 Vol 13,#11 page 74

Hand Hygiene and GarbingAre these compounders cleanroom ready?

Hand Hygiene and GarbingWatch out for some gowns-Examine the COA

Hand Hygiene and GarbingConsistency with Visual Observations VS What

Inspectors See

Hand Hygiene and GarbingCommon Deficiencies Observed

• Not re-sanitizing gloved hands when returning to ISO 5 to compound

• Improper staging of items to be brought into the ISO 7 buffer room prior to compounding

Hand Hygiene and GarbingCommon Deficiencies Observed

• Leaving ISO 8 environment with shoe covers on and sometimes even entire garb, then not re-garbing upon re-entry into ISO 8 from unclassified area

• Insufficient washing of hands to the elbows

• Nail Hygiene deficiencies

Hand Hygiene and GarbingDocumented Annual Observations of

Compounding Personnel vs Inspectors• Per USP <797>, a qualified aseptic compounding expert attests to the observations of hand hygiene and garbing and documents their observations (example of the form in Appendix III of the USP <797> chapter)

Hand Hygiene and GarbingDocumented Annual Observations of

Compounding Personnel vs Inspectors• What inspectors are observing at times may not be consistent with the documented visual observations of the pharmacy• Example: Nail polish or artificial nails, make up, jewelry

• Not donning beard covers if compounder has facial hair

• Not cleaning under nails

Hand Hygiene and GarbingRisk of Touch Contamination of Gloves

• Increased risk after improper staging

• Leaving ISO 5 (LAFW, BSC) to touch other non-sterile objects in ISO 7 or greater air then returning to ISO 5 and not re-sanitizing gloved hands

Hand Hygiene and GarbingRisk of Touch Contamination of Gloves

• Continuous compounding or challenging media fills

• Adjusting face mask

• Reaching out of ISO 5 to use bar code device or computer screen

Hand Hygiene and GarbingObserved Garbing Excursions and Breaches

• Glove sleeves of Isolator (CAI, CACI) rip • Consult the Barrier Isolator manual

• Shoe covers do not completely cover sneakers exposing ankles

Hand Hygiene and GarbingObserved Garbing Excursions and Breaches

• Gown not completely sealed at the back

• When exiting the chemo room doffing off single gown, then exiting via the shared anteroom clean side of LOD without gown

• Hair bouffant does not fit all hair underneath the elastic circumference

Hand Hygiene and GarbingCleanroom Etiquette-DON’T’s

• No chewing gum while compounding• No cups or water into cleanroom• No leaning into ISO 5 zone during compounding

• No compounding if compromised with a sunburn or rashes

• Remove jewelry-it can interfere with the effectiveness of the PPE

United States Pharmacopoeia USP 39-NF 34

Hand Hygiene and GarbingUnderstanding of Persistent Activity Products

Hand Hygiene and GarbingPersistent Activity Products Pearls

• Some features of a persistent activity agent• Demonstrate non-inferior antibacterial efficacy immediately after use

• Able to demonstrate superior persistent activity after 6 hours of glove wear compared to other agents

Hand Hygiene and GarbingPersistent Activity Products Pearls

• The agent should be bactericidal in the shortest contact time on the hand

Chojecka et al. Neutralization efficiency of alcohol based products used for rapid hand disinfection; 2017;68(4):389-394

Hand Hygiene and GarbingPersistent Activity Products Pearls - Continued

• Some features of a persistent activity agent • Review the manufacturer’s product sheet (COA) for efficacy

Daryl Paulson Infection Control today Persistent and Residual Antimicrobial Effects : Are they important in the Clinical Setting? Accessed October 18, 2018

Hand Hygiene and GarbingPersistent Activity Products Pearls - Continued

• Don’t place regular non persistent products next to persistent activity products-this confuses the compounder (ex plain Purell)

• Chlorhexidine gluconate 1% Solution and or Ethyl Alcohol 61% w/w (varying percentages)

Daryl Paulson Infection Control today Persistent and Residual Antimicrobial Effects : Are they important in the Clinical Setting? Accessed October 18, 2018

Hand Hygiene and GarbingExamples of Agents with Persistent Activity

• Avagard

• Sterillium Rub

• Purell Waterless Surgical Scrub• Some cleanrooms have plain Purell which is incorrect

Centers for Disease Control and Prevention. Guideline for hand hygiene in health-care settings.MMWR.October 25, 2002; 51(RR-16):1-44

Hand Hygiene and GarbingExamples of Agents with Persistent Activity

• When choosing a persistent activity product review the supporting documentation for persistent or extended activity

• Must be applied on hands prior to donning sterile gloves

Centers for Disease Control and Prevention. Guideline for hand hygiene in health-care settings.MMWR.October 25, 2002; 51(RR-16):1-44

Hand Hygiene and GarbingSelection of Gloves used in compounding

• Sterile

• Powder free

• Nitrile or Neoprene vs Latex

Hand Hygiene and GarbingSelection of Gloves used in compounding

• Use of sterile gloves• Single pair acceptable for Non-hazardous compounding

• Double gloves for Hazardous compounding

• Examine product information for gloves -to suggest rated for handling hazardous drugs• Conformance to ASTM 6978 standards

Questions?

Certifications Importance of reviewing Certification reports

prior to an inspection

CertificationsThe What, the When, and the How

Certifications The What

A Certification is an independent evaluation of the critical environments

Certifications The When

• Prior to operation• Every six (6) months• When equipment is moved, replaced

or repaired

Certifications The How

• Must be conducted by a CETA certified agent

• Equipment used by agent must be calibrated annually

• Certifier must follow garbing procedure of facility

• Dynamic Conditions

Review of a Certification Report

• Primary Engineering Controls• LAFW• BSC• CAI• CACI

• Secondary Engineering Controls• Ante Room• Buffer Room

Review of a Certification Report -Continued

Primary Engineering Controls

Smoke Studies Non Viable Air HEPA Filter Leak

Testing

ISO Class (Non Viable Air)

Smoke Studies HEPA Filters Vented to outside

LAFW 5 Yes Yes No

CAI 5 Yes Ante Chamber and Main Chamber

CACI 5 Yes Ante Chamber and Main Chamber

BSC * 5 Yes Yes Yes

*Alarm Testing

Secondary Engineering Controls Non Viable Air HEPA Filter Leak Testing Air Changes Per Hour Pressure Differential – Ante Room

and Buffer Room

Certifications Review of a Certification Report - Continued

ISO Class (Non Viable

ACPH Pressure Differential

HEPA Filters

Ante Room 8 20 0.02 – 0.05* Leak Tested

Buffer Room 7 30 0.02 – 0.05* Leak Tested

Buffer Room – Hazardous **

7 30 < -0.01* Leak Tested

* Inch Water Column** CACI for compounding minimum of 12 ACPH

What else could be part of the report? Viable Sampling Air Surface

• Are they Actionable or Non-Actionable?• Remediate immediately

• What do we do with these results?• Trend

ISO Class AIR (cfu’s per cubic meter)(1000 liters of air per plate)

SURFACE (cfu’s Per

Plate)

5 >1 >3

7 >10 >5

8 >100 >100

• Identify to the genus level• Actionable organisms

• Gram Negative Rods• Coagulase Positive Staph• Molds• Yeast

• Remediation• What is the source?

• Personnel work practices• Cleaning procedures• Operational procedures• Air filtration efficiency

• Remediation• Immediate• Documentation• Resample

Trending of Bioburden

January 2017 July 2017 January 2018 July 2018

Surface Sampling Trending

LAFW 1 Organism CFU's LAFW 2 Organism CFU's

Questions?

Certifications Dynamic Conditions

CertificationsSignificance of Smoke Studies

Certifications PEC VS SEC

Questions?

MEDIA FILLS AND GLOVE FINGER TESTS

Clear documentation of Incubator temperatures, length of incubation

Low, Medium and High-risk Media fill testing

Glove Fingertip Sampling

• New personnel• Annual or Semi-Annual • Random

Glove Fingertip Sampling - Continued

• Media • Technique• Incubation• Documentation

Questions?

CLEANING

Cleaning

• Importance of Cleaning Documentation• Accountability• OOS remediation• Training requirements

• Initially (before compounding)• Annually/semi-annually (after media fill – DCA)

• EVS / Housekeeping records• Common Observations

Cleaning

• Review of Cleaning Documentation• Non pharmacy staff housekeeping/EVS• Who’s watching?• EVS competencies• Shall be evaluated by qualified

compounding expert

Cleaning

• PEC’s• Most critical• Cleaning and disinfecting of surfaces

required• Must allow 30 seconds for sIPA to dry• Documentation • Common Deficiencies

• PEC’s (continued)• Implement DCA SOP

• Critical factors to consider• Dwell times: bleach < or = 1 min

bact; 5-10 min for spores *• Effectiveness • RTU vs dilution

*5,000ppm chlorine soln against C difficile spores- Reference: “American Journal of

Infection Control”, August 2005, pgs 320-325.

Cleaning

• SEC’s• Work surfaces: daily

• Ante room• Buffer rooms• SCA’s• Agent must not degrade ISO 7 or 8 air

quality (USP <1072>)

Cleaning

• SEC’s (continued)• Floors

• required to be done daily• ISO 7, ISO 8 and SCA’s• Follow SOP• Consider germicidal compatibility with

surfaces (USP <797> appendix II)

Cleaning

• Factors to consider in choosing chemicals• Compatibility• Effectiveness• Toxic Residues

CleaningUSP <797> Appendix II

Cleaning

• SEC’s (continued)• Monthly cleaning

• Shelving, ceilings and walls• Careful consideration when cleaning

ceiling

CleaningCleaners VS Disinfectants

Cleaner• Removal, usually with detergent and water or

enzyme cleaner and water, of adherent visible soil, blood, protein substances, microorganisms and other debris from the surfaces, crevices, serrations, joints, and lumens of instruments, devices, and equipment by a manual or mechanical process that prepares the items for safe handling and/or further decontamination

Source: www.cdc.gov/infectioncontrol/guidelines

CleaningCleaners VS Disinfectants - Continued

Disinfectant

• Usually a chemical agent (but sometimes a physical agent) that destroys disease-causing pathogens or other harmful

microorganisms but might not kill bacterial spores. It refers to substances applied to

inanimate objectsSource: www.cdc.gov/infectioncontrol/guidelines

• Cleaning is a mechanical process• Cleaning prepares a surface for disinfection• Cleaning agents contain surfactants and/or

detergents to remove dirt, debris and microbes

• Many cleaning agents work to disinfect but does not replace the need of sIPA!

• EPA Registered One-Step Disinfectant Cleaners• Cavicide• Pre-empt RTU• Vesophene llse• Sporicidin• Peridox RTU• Oxivir Five 16 concentrate• Spor - Klenz

sIPA and sodium hypochlorite do not contain surfactants or detergents

CleaningTools and Materials

• Non-shedding wipers, mops and sponges • Dedicated to use in buffer rooms, ante-are

and SCA’s• MUST NOT be removed from these areas

CleaningTools and Materials – Continued

• Considerations• EVS / Housekeeping bringing cleaners from

outside• Are they diluting agents?• What is the stability of diluted agents?

CleaningPolicy and Procedure

• Who, What, Where, When, How• WHO cleans what?

• EVS vs Compounding personnel

CleaningPolicy and Procedure - Continued

• Who, What, Where, When, How• WHAT?

• Cleaning/disinfecting agents- RTU or dilution?• Include dilution instructions

• Non shedding mops/ wipes• Mop handles

• Who, What, Where, When, How• WHERE?

• Ante room• Buffer rooms• PEC’s• SCA’s

• Who, What, Where, When, How• WHEN?

• Daily (floors and work surfaces)• Weekly (optional)• Monthly (ceilings, walls, storage

bins, shelving)• Frequently (PEC’s)

• Who, What, Where, When, How• HOW?

• Method of Cleaning • PEC’s : CAI’s, CACI’s, LAFW’s,

BSC’s• SEC’s: floors, ceilings, walls,

shelving, storage bins

• Do you have a DCA Policy?• Different requirements for LAFW’s, CAI’s,

CACI’s, and BSC’s• Include deactivating agents,

disinfectants, non shedding wipes, tools (for CAI, CACI)

• Consider changing pre-filters according to manufacturer recommendations

Questions?

Compounding Records

• Provide a history of:• How the CSP was prepared• Who prepared it• What was used to prepare it• When was it prepared

Compounding Records

• Communication• Accountability• Regulatory Requirements• Quality Improvement

Compounding RecordsElements of a compounding record

• Name, strength, and dosage form of the medication

• Equipment needed• Methodology• BUD

Compounding RecordsElements of a compounding record - Continued

• Quantity• Total theoretical yield for the CSP (# of csp’s

expected)• Total actual yield of CSP’S( # of csp’s prepared)

Compounding RecordsFinal Reconciliation

The final packaging and CSP yield information should be reviewed, reconciled, and approved

Questions?

Class III Permits

Class III PermitsOverview

• Beginning on October 19, 2018, the Board of Pharmacy began issuing permits for Class III Institutional Pharmacies.

• Rule Reference: 64B16-28.750, Florida Administrative Code

Class III PermitsOverview

• Class III institutional pharmacy permits were created for hospital-affiliated institutional pharmacies, including central distribution facilities that provide the same services authorized by a Class II permit.

• Rule Reference: 64B16-28.750, Florida Administrative Code

Class III PermitsOverview - Continued

• Class III Institutional permitees may:

• Dispense, distribute, compound, and fill prescriptions for medicinal drugs;

• Prepare prepackaged drug products;• Conduct other pharmaceutical services for

the affiliated hospital and for entities under common control that are each permitted under Chapter 465, F.S., to possess medicinal drugs; and

• Provide the aforementioned services to an entity under common control that holds an active health care clinic establishment permit as required under Chapter 499, F.S.

• A Class III Institutional Permit may be issued to existing Class II or Modified Class II Institutional Pharmacy Permittees or as an initial permit to new pharmacy facilities meeting the statute’s requirements or Central Distribution Facilities under common control with a hospital.

• The term “common control” is defined as the power to direct or cause the direction of the management and policies of a person or an organization, whether by ownership of stock, voting rights, contract, or otherwise.

• Change of Association for Existing Permittees. Institutional Pharmacies affiliated with a hospital currently holding Class II or Modified Class II Institutional Pharmacy Permits may request the facility be associated as a Class III Institutional Pharmacy Permit by completing an application (Form DH5033).

• Because pharmacy permits are non-transferrable, this option is not available if there is any change in the ownership or identity of the business entity holding the existing Class II or Modified Class II Institutional Pharmacy Permit.

• Upon approval of the request, the existing Class II or Modified Class II permit will be re-associated as a Class III Institutional Pharmacy Permit, with no change of permit number.

• New Class III Permits. Applicants for a new Class III Institutional Pharmacy permit must complete an application (Form DH5032).

• Applicants for an Institutional Pharmacy Permit must designate a consultant pharmacist of record as required by Section 465.019, F.S. and Rule 64B16-28.501, F.A.C.

• A copy of the permittee’s policy and procedure manual as provided herein shall accompany the permit application.

• As required by paragraph 64B16-28.100(1)(c), F.A.C., prior to issuance of a Class III Institutional Pharmacy Permit, the applicant must pass an on-site inspection.

• For applicants who currently hold Institutional Class II or Modified Class II permits, the on-site inspection required for issuance of the Class III permit shall be coordinated, to the extent practicable, with any other inspections required or recently conducted, and in no event, shall reset or disrupt the permittee’s existing inspection schedule.

• Each applicant must comply with the fingerprinting requirements of section 465.022, F.S., unless the applicant qualifies for the statutory exception for corporations having more than $100 million of business taxable assets in Florida

Class III Permits

• Please visit the Board of Pharmacy Resources page to download the application form for the Class III Pharmacy and Change of Permit Association for the Class III Pharmacy.

Class III Permits

• Staff Processors for Class III Pharmacies: Shekinah Dawkins or Ahjia Ponders.

• Board of Pharmacy Telephone: (850)245-4292

• E-mail address: MQA.Pharmacy@flhealth.gov

Questions?

REFERENCES*

• Centers for Disease Control (CDC)• USP <797>• Critical Point LLC.• PDA• FDA Guidance

*If not indicated on slide

Medical Quality AssuranceBureau of Enforcement/

Investigative Services Unit850-245-4478

bureau of enforcement investigative services unit...

Documents

firearms investigative & enforcement services ... -...

federal energy regulatory commission...

procedures for handling cash transactions related to ... ·...

investigative bible study - cru the life-giver study...

an enforcement update from usao and oig · an enforcement...

oracle siebel investigative case management white · siebel...

1. background: nsf oig investigations who are we? special...

anti-cartel enforcement manual...anti-cartel enforcement and...

unclassified1 law enforcement response to piracy:...

amazon web...

anti-cartel enforcement manual · anti-cartel enforcement...

training guide for enforcement and investigative...

cover - agsa reports... · 2020. 12. 9. · cidb...

2014 fcpa year in review - steptoe.com · while the...

naval criminal investigative service computer...

anti-cartel enforcement manual - international competition...

forensic services division - oregonprogram overview the...

journal of criminal interpreter-mediated police year 18...

adopted december 3, 2012 · improvement of enforcement case...

unicorn riot - your alternative mediathe ice office of...